- Novartis' generics unit is claiming that United Therapeutics, a Maryland-based biotech, has engaged in anticompetitive measures to thwart copycat versions of its top-selling drug from snagging market share.
- Sandoz, along with its commercialization partner RareGen, said in a lawsuit filed Wednesday that United put "artificial restrictions" on cartridges needed for subcutaneous delivery of Remodulin, a pulmonary arterial hypertension (PAH) drug responsible for close to 40% of United's revenue.
- Sandoz launched a copycat version of Remodulin in March, but claims generic competition has been blocked by United forming a pact with the cartridges' manufacturer, Smiths Medical. United said in a statement the claims are meritless and that it expects to win in court.
United leans heavily on Remodulin (treprostinil) sales to support its wider business. Unsurprisingly, the company has worked to expand and safeguard the franchise in recent years as generic threats became more realized.
About a year ago, the Silver Spring, Maryland-based company agreed to acquire SteadyMed in a deal valued at $216 million. At the time, SteadyMed was developing a drug-device combination called Trevyent that paired its disposable PatchPump technology with a two-day, subcutaneous supply of treprostinil for the treatment of PAH. United noted in several financial reports how the combo product could be a potential competitor to Remodulin.
Additionally, United has linked up with medical device makers Medtronic and DEKA Research and Development to create new treprostinil delivery systems. The system made in partnership with Medtronic uses an implantable infusion pump and gained Food and Drug Administration approval in July 2018, though it hasn't launched yet because Medtronic still needs to meet certain conditions laid out in the device's pre-market approval.
United said in late February it was preparing to submit both Trevyent and and the DEKA device for approval. Company leadership estimated that the three devices should expand the number of PAH patients who receive a United therapy by 5,000 to 10,000.
New devices, however, are unlikely to fully protect United's top-seller. Jefferies analyst Eun Yang wrote in an April 8 investor note that the expectation is Remodulin use will decline over time as generic competition sets in. Taking into account the recent launch of generic Adcirca (tadalafil), an Eli Lilly drug to which United has U.S. commercial rights in PAH, Yang models year-over-year revenue declines of roughly 21% in 2019 and 11% in 2020 for United.
And now, United also has to contend with a legal challenge from Sandoz.
United and Smiths "have cornered the market," claimed Sandoz and RareGen in their lawsuit, which was filed in the U.S. District Court for New Jersey.
"They have enough cartridges and resin to supply the entire market — for subcutaneous injections of Remodulin and for generic treprostinil. That entire supply, however, is now dedicated to Remodulin."
According to the lawsuit, Smiths was telling distributors and pharmacies not to dispense or sell cartridges for use with generic Remodulin — part of what Sandoz and RareGen describe as a broad scheme meant to help United maintain a "monopoly over a large segment of the market that it does not deserve and has not earned."
United, meanwhile, is suggesting the litigation is the result of two bitter companies that didn't adequately prepare before launching their generic.
"This lawsuit stems from Sandoz's and RareGen's failure to take similar steps to ensure availability of a system to deliver their product, despite having eight years from filing Sandoz's Abbreviated New Drug Application (ANDA) to do so," United said in an April 17 statement.
"Sandoz and RareGen now seek to make us responsible for their failure to properly plan to serve their prospective patients," the company added.